Adjuvant Chemotherapy for Locally Advanced Cervical Cancer (ACT-LACC)

Siriwan Tangjitgamol, MD

Status and phase: Unknown; Phase 3

Conditions: Uterine Cervical Cancer

Treatments: Radiation: Pelvic radiation; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02036164

COA-CREC 002/2013

20140106001 (Registry Identifier)

Details and patient eligibility

About

Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Full description

Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years
• Cervical cancer FIGO stage IIB-IVA
• Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
• ECOG performance status 0-2
• No history of other cancer except basal cell carcinoma
• Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
• Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
• Consent to participate

Exclusion criteria

• Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
• Adnexal mass from physical examination or imaging study
• Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Concurrent chemoradiation

Active Comparator group

Description:

Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy

Treatment:

Drug: Cisplatin

Radiation: Pelvic radiation

Concurretn chemoradiation plus adjuvant chemotherapy

Experimental group

Description:

Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin * Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy * Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT * Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Cisplatin

Drug: Carboplatin

Radiation: Pelvic radiation